Small businesses are stressful to drive. If a small and medium-sized company continues to struggle with its routine quality problems, there are far fewer chances that the company can sustain and grow. Therefore, the most advantageous tool for a small company to achieve sustainability in its processes is ISO 9001 certification. A small company can reap significant benefits from the systematic approach to the process provided by the ISO 9001 standard. Let’s see how the practical implementation of ISO 9001 standard benefits SMEs to improve their various processes and activities.

Why ISO 9001 certification?

The ISO 9001 standard is a basic structure for any organization, large or small, to ensure a good quality management system. The purpose of the standard is to allow a company to provide higher levels of customer satisfaction, along with the constant supply of products or services that meet the needs of customers, as well as the achievement of business goals and targets and to maximize profitability. ISO 9001 certification can help a small company in specific areas, in particular in the coherence of company processes and relationships with suppliers. Here are some examples of how the ISO 9001 standard helps SMEs:

ISO 9001 certification can help SMEs to increase their business and, ultimately, their profitability, establishing business with clients for whom certification is a contractual requirement.

ISO 9001 allows SMEs to get a clear understanding of their business by collecting all the valuable business information and data required by the various standard requirements.

ISO 9001 provides the basis for the development of a system that increases confidence in company stability, while providing reliable and recorded information and data to identify and advance with possible improvements.

ISO 9001 certification benefits all aspects of a business. Some of the key benefits of ISO 9001 certification are the following:

Quality Manual – ISO 9001 Manual is a typical form of main document used in drawing up and implementing a quality system. It is expected to provide an adequate description of the Management intention to fulfill system requirement while serving as a permanent reference for implementation and maintenance of the system.

Steps to be followed while preparing ISO 9001 Manual

An ISO 9001 Manual should be first evolved by the Chief Executive. He can take the help of senior managers.

A person from the steering committee who is from the top management should write the Quality Manual. In most of the cases, the management representative writes the manual.

Based on the company’s ISO 9001 Quality Policy, the broad objectives and activities for each department have to be decided and fitted into the relevant clauses. For this, the department heads should give draft write-up of the activities in their department. Then it should be meticulously scrutinized to ensure that the system is sufficient to achieve the company’s Quality Policy objectives or benchmarks. The clauses applicable to each department of the company are identified.

Organisation chart should be chalked out and the responsibility and authority of each personnel mentioned in the organisation chart should be documented. Personnel authorized to take decisions must be included in the organisation chart. Preparation of the chart will help in identifying and documenting the responsibility for activities under each clause.

A suitable numbering system, department wise and clause wise should be decided which can be made applicable to the remaining tiers of documentation. This will help in cross-referencing ISO 9001 quality manual with other tiers of documentation like, procedures, work instructions and records. It is very important that all the tiers should have cross linkages with each other.

No confidential document / procedure should be included in the Quality Manual because it is an open document.

After preparing the draft of ISO 9001 Manual it should be circulated to all department heads to ensure that there is no discrepancy or that no important activity it left out.

After their approval, the final draft should be prepared. The final draft should have company name and logo, issue number, issue date, controlled-copy identification on each page, page number and signature of preparing and approving authority.

ISO 9001 states that the purpose of an ISO 9001 internal audit is to determine whether a quality management system of an organisation:

Meets your requirements for a QMS, and the requirements of the standard; and

Is implemented and maintained effectively.

The most important task of the ISO 9001 internal auditor is to continuously monitor the effectiveness of the QMS and help senior staff determine whether the quality objectives are aligned with the organisation’s business objectives.

In smaller organisations, the internal auditor often helps to prepare for ISO 9001 certification or maintenance visit. Therefore, it is very useful to have a solid knowledge of the requirements and processes involved in the ISO 9001 certification audit.

The smaller organizations will probably only need an ISO 9001 internal auditor, but larger organizations often require multiple internal auditors to focus on different departments. Appointing internal auditors for different departments increases accountability and reduces the possibility of errors.

Their work, and the help they provide, isn’t finished after the QMS has been implemented and the audit has been completed. They will continue to monitor the QMS and make recommendations to maintain compliance.

The general auditing skills required to become an ISO 9001:2015 internal auditor can also be used in environments outside those related to the Standard. Furthermore, internal auditors are valuable to organisations that audit third-party suppliers, as they can check that suppliers have adequate security controls in place.

The first step in building an ISO 9001 Quality Management System is the creation of a “Quality Manual“. This is a separate and distinct step from developing quality procedures. The aim is to establish, in a short and concise format, the policies and objectives of the company required to achieve a desired level of quality for the organization or division.

ISO 9001 manual should be the document where the organization itself, its quality management system, and even his way of thinking and this quality management approach.

What should your ISO 9001 manual contain?

How you can define the contents of your ISO 9001 manual, include only what is useful for your company. So what should you write in the ISO 9001 quality manual? Add the information that will guide current and future employees as they build the business you imagined:

The objectives and vision of your company: To set the tone for your ISO 9001 manual, start with the answer to a question: Why does this company exist? Remember, your company does more than just making a product or providing a service. Its purpose involves improving people’s lives in a specific way. Figure out how, and write that down.

Products and services: For any product you create or service you fulfil, define the process behind it in the ISO 9001 manual. The quality depends to a large extent on consistency, therefore, clarify your expectations.

The definition of quality management system of your company: By itself, the word ‘quality’ is vague. Specifically define what is important to your client.

The relationship between different departments: Few products come from just one department. Be sure to define how different parts of your company work together. The easiest way to do this is with a clear flow chart.

The internal audit is one of the most important tools for driving improvement in an ISO 9001 Quality Management System (QMS), it is vital that you have internal auditors who have the skills needed to properly review your processes and records and identify the strengths, weaknesses, and problems that are occurring in your organization.

In order to ensure this competence, it is important that you make sure your internal auditors are properly trained and experienced to do the job well. ISO 9001:2015 internal auditors training helps to provide the people conducting the internal audits in their firms to understand the process, follow the correct procedures, and lead auditing teams.

What does an effective ISO 9001:2015 auditors training should cover?

understanding the ISO 9001 quality management system standard, including the ISO 9001 requirements and structure

using the ISO 9001 standard for auditing management systems to assess company processes against requirements

role play of different auditing situations to enhance auditing skills

What are the benefits of ISO 9001:2015 auditor training?

After getting ISO 9001:2015 training, an internal auditor can be qualified internal auditor in the organization and it able to:

Understand the structure of QMS

Understand the processes involved in auditing

Plan, manage, and schedule an audit program

Develop a cost-effective and compliant audit system

Provide value addition to the system

Global Manager Group offers an extensive range of services to help with preparation for certification, maintaining compliance and ensuring improvement. One of our services is that of ISO 9001:2015 internal audit training. With various courses available, we enable your relevant employees to develop the needed skills to conduct such audits as required.

One of the most important checking tools in a Quality Management System (QMS), is the internal audit. The requirements of ISO 9001:2015 are very clear that this is a critical element of your QMS; and, as you want to know how your processes work, your internal audits become a key resource. ISO 9001:2015 Audit Checklist are a widely used and important tool to insure that when performing an internal audit.

What is the ISO 9001: 2015 standard required by the internal audit?

To better understand the why and how of internal audit checklists, it is helpful to understand what the ISO 9001:2015 requirements state about why we do internal audits. The ISO 9001:2015 internal audit is there to perform two functions:

to make sure that the processes are meeting the planned arrangements that the company has identified for the process in the QMS and any requirements that the IOS 9001:2015 standard has in place for that process

to make sure that the process is effectively implemented and maintained

So, when creating ISO 9001:2015 audit checklists, you want to include the information needed to verify these two process results correctly.

How to create an ISO 9001:2015 Audit Checklists to check conformance?

An internal audit is there to witness the outcome of a process through a review of records or witnessing the actions of the employees, and to then compare this to the planned arrangements for the process to see if what is being done is what was planned. As can be seen above, there are two sets of planned arrangements to check: those required by ISO 9001:2015 and those that the company has put in place for their process to work.

An audit checklist is basically a set of questions that the auditor wants to ask, or activities that the auditor wants to witness, in order to verify the planned arrangements as above. The checklist is created by reviewing the ISO 9001:2015 standard and any documented procedures or undocumented processes for the activity to determine what should happen. The ISO 9001:2015 audit checklist could include questions on supplier evaluation and a review of the supplier audit reports that have been collected to see if they are done when determined by the QMS.

The checklist can include more than just questions; it can also include statements from the procedures that the auditor wants to check. The checklist is a tool for the auditor, and it is not something that the controlled entity should complete, so any format or questions and statements will be useful for the auditor to ensure that all the important parts of the process are checked will work.

ISO 9001:2015 is a widely used standard for quality certification and also one of the most stringent. This standard ensures that all aspect of a contract manufacturer’s business are well-managed and continually improved, including key processes, management roles and responsibilities, ISO 9001:2015 documentation, customer satisfaction, employee training, vendor performance and internal audits.

Certification audits are used to evaluate the effectiveness of and assess conformity to documented Procedures and Work Instructions, and identify opportunities for improvement. During an ISO 9001:2015 audit, a manufacturer’s quality system is measured against the requirements of the standard. More than just a method of checking practice against procedure, audits are a powerful tool in manufacturing improvement processes. Below please find 3 tips to ensure a successful audit:

1. Review ISO 9001:2015 documentation: Ensuring that all company ISO 9001:2015 documentation, from packing slips to check sheets to invoices is thorough and accurate is essential to completing an audit successfully. Common elements to monitor include missing signatures, incomplete fields, and outdated revision levels. Also, check the handwritten notes on drawings and work instructions – these can be triggers that indicate a need for a new revision to the document.

2. Communicate: During the ISO 9001 audit, employees should answer questions openly and honestly. If they do not know the answer to a question, or if the question is not related to their role, they must inform the auditor. Referring an auditor to a Department Manager or referencing where the answer can be found is always acceptable. Providing misinformation under the guise of being helpful, or speculation on hypothetical situations, can potentially make things difficult for everyone involved. Employees should focus on answering the questions at hand.

3. Involve Everyone: Employees should be encouraged to contribute to the QMS and informed of improvements generated from their input. This is a powerful motivator and enhances a culture of employee engagement. When one has a stake in the success, they are more motivated to participate. It also makes one more knowledgeable of the QMS to enhance the processes in their departments.

ISO 9001:2015 certification requires manufacturers to constantly review, improve and document the processes in their facility to ensure that they are running at the highest standard possible. The main objective of ISO 9001:2015 certification audit is to enable manufacturers to evaluate their quality management systems, identify opportunities for improvement, and generate creative, effective and efficient solutions. Audits are performed to check practice against procedure, but the benefits to the manufacturer extend far beyond this objective. ISO 9001:2015 audits ensure that manufacturing companies are optimized, competitive, and deliver the highest quality and value to their customers